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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Button, Nasal Septal
510(k) Number K982667
Device Name MICROMEDICS NASAL SEPTAL BUTTON
Applicant
MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN,  MN  55121
Applicant Contact CHARLES GROTE
Correspondent
MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN,  MN  55121
Correspondent Contact CHARLES GROTE
Classification Product Code
LFB  
Date Received07/31/1998
Decision Date 11/24/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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